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Wednesday, August 23, 2017
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Rivaroxaban approved for stroke prevention in non-valvular atrial fibrillation

Henry I. Bussey, Pharm.D.
November, 2011

Rivaroxaban (brand name Xarelto), an oral anti-factor Xa (FXa) inhibitor, was approved on Nov. 4, 2011 for stroke prevention in individuals with non-valvular atrial fibrillation. The FDA report (http://www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/ucm278646.htm
) indicates that the product information will contain a boxed warning advising individuals taking the drug to consult their health care professional before discontinuing the drug because of an increased risk of stroke following discontinuation of the drug. According to CardioSource, the FDA's Cardiovascular and Renal Drugs Advisory Committee recommended that rivaroxaban should only be offered as a third-line therapy (behind warfarin and dabigatran); but such a limitation was not addressed in the FDA approval announcement. In the ROCKET AF (atrial fibrillation) trial with rivaroxaban vs warfarin, there was no "signal" of an increased risk of myocardial infarction with rivaroxaban as was seen with dabigatran in the RE LY trial (and discussed on ClotCare at clotcare.org/dabigatran_vs_warfarin.aspx). In addition, the issue of 30-day or 60-day product stability with dabigatran (also discussed on ClotCare at clotcare.org/dabigatran_special_handling.aspx) has not been an identified problem with rivaroxaban. It would seem, therefore, that choosing between either of the new agents (rivaroxaban or dabigatran) involves weighing product-specific limitations for each agent.

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Wednesday, August 23, 2017